Pain and Safety of Microneedles in Oral Cavity

Pain and Safety of Microneedle Application in the Oral Cavity of Human Volunteers

A randomized, crossover, double-blind, placebo-controlled, one-session clinical trial with 30 male volunteers was performed to access pain and safety of microneedle topical application in different regions of the oral cavity.

Study Overview

• Status: Completed
• Conditions: Oral Cavity Disease
• Intervention / Treatment: Other: Microneedle; Other: Hypodermic needle; Other: Flat patch

Detailed Description

A randomized, crossover, double-blind, placebo-controlled, one-session clinical trial with 30 male volunteers was performed by applying a microneedle patch in the following regions of the oral cavity: lip (inner lower), buccal (cheek: 1 cm behind the month angle), tongue (dorsal surface), hard palate (anterior region), and attached gingiva (between central and lateral upper incisors). A 30 gauge hypodermic needle and an identical patch but without microneedles sticking out, were used as positive and negative controls, respectively. The application force was standardized to 10N by an applicator composed of a 5 mL syringe and a spring. Insertions were performed with a gap of 30 seconds. Pain and discomfort associated to the procedure was evaluated with a Visual Analogue Scale (VAS), by a blinded-dentist. The safety associated to microneedle application was verified immediately after the application (0h) and after the next day (24h). The different application sites were inspected visually for bleeding, ulceration, bruising, redness or swelling.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Piracicaba, São Paulo, Brazil, 13414903
      • Michelle Franz Montan Braga Leite

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

- Healthy male

Exclusion Criteria:

- Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders, smokers or alcoholic.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Microneedles; Application of microneedle patch, 30G hypodermic needle (positive control) and flat patch (negative control) in the lip, buccal, tongue, palatal and gingival mucosa for pain and safety assessment

Other: Microneedle; A microneedle patch (no drug) was applied in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa to access pain, discomfort and safety.; Other: Hypodermic needle; 30 gauge hypodermic needle was inserted in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.; Other Names: positive control; Other: Flat patch; A flat patch was applied in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.; Other Names: negative control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain sensitivity assessment by Visual Analogue Scale after microneedle application in the oral cavity	Pain was evaluated after microneedles, hypodermic needle or negative control topical application application in different oral cavity sites	30 seconds
Number of participants with treatment-related adverse events as assessed by visual inspection of ecchymosis, ulceration, redness, swelling or bleeding after microneedles use in the oral cavity	Any sign of ecchymosis, ulceration, redness, swelling or bleeding right after and 24 h later applications of the devices in different oral cavity sites	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmation of mucosal perforationin the oral cavity after application of the devices	Mucosal perforation after microneedles application was confirmed by applying gentian violet to stain the sites of microneedle insertion	Right after microneedle application

Collaborators and Investigators

• Sponsor: University of Campinas, Brazil
• Collaborators: Texas Tech University
• Investigators: Principal Investigator: Michelle Leite, PhD, University of Campinas, Brazil; Principal Investigator: Harvinder S Gill, PhD, Texas Tech University

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2018
• Primary Completion (Actual): May 25, 2018
• Study Completion (Actual): December 16, 2018

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Buccal mucosa; Microneedles; Transbuccal administration
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases
• Other Study ID Numbers: CAAE: 42926115.3.0000.5418

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No